Unproven stem cell therapies: an evaluation of patients’ capacity to give informed consent

Capitalising on the hype surrounding regenerative medicine, there are clinics worldwide marketing unproven stem cell-based therapies to patients. Some patients have travelled overseas to access treatments they believe are safe and effective. This practice, known as stem cell tourism, could result in adverse effects in some patients. This paper seeks to examine how the industry could threaten the validity of the patient’s informed consent. The vulnerable groups include adults, minors and incompetent patients. Since patients are exposed to exaggerated claims and inaccurate information, this article argues that each cohort may not truly consent to such therapies. While each group hopes to obtain a miracle cure, the reality is that these purported medical treatments may not enable patients to give their informed consent, which thereby inhibits good decision-making. Accordingly, states could restrict patients’ access to unproven stem cell-based therapies to control the problem. This paper illustrates how the regulatory framework in countries such as Australia and the United States (U.S.) has allowed the industry to thrive. Recommendations on how states can take a restrictive stance against this complex phenomenon are proposed.